Newsletter | May 21, 2026

05.21.26 -- Minimizing Regulatory Risk For Biologics Manufacturing Changes

INDUSTRY INSIGHTS

Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective

This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.

FEATURED EDITORIAL

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

Minimizing Regulatory Risk For Biologics Manufacturing Changes

Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.